In the medical field, sterile fluids, such as medicaments, pharmaceuticals, sterile saline solutions and so on are frequently required. Such sterile fluids are typically supplied in rigid bottles or vials made of glass or plastic, or in collapsible containers.
Bottles for sterile fluids are typically closed by a rubber stopper inserted into the mouth of the bottle. The stopper is designed so that it can be pierced by a needle, an infusion spike, or the like, to allow the contents of the bottle to be withdrawn. In some designs the stopper can be removed to allow the contents of the bottle to be poured out. In order to hold the stopper in place different kinds of over-seals exist, such as a cap made of aluminium or similar thin sheet metal being crimped over the stopper and the upper part of the bottle. Over-seals can also be made of plastic. In order to gain access to the stopper, either to pierce it or remove it, the cap, or a part of this, is either partially or totally torn away. Commonly-assigned WO00/03920 describes an example of a package on the market comprising a plastic bottle, a stopper and a plastic cap. The cap comprises a cover member which supports the stopper and which has a region that is removable to expose the outer surface of the stopper.
When transferring sterile fluids from such known packages to a syringe, cartridge or an infusion pump the stopper is typically pierced with the needle of a syringe, or the fluid is transferred to another container by removing the stopper and pouring out the content or siphoning this with a tube (also called a straw or a quill). The use of a needle always poses a prick risk for the operator, in addition to the risk of transferring small particles from the stopper to the fluid to be injected in a patient. Further, whether pouring or siphoning out the contents, many operating steps are needed in order to transfer the bottle content to a syringe or a cartridge before the content can be administered to the patient. For example, commonly-assigned EP11193737.1 discloses a package comprising a container, a connecting plug and a cap. The connecting plug functions as an integrated connection for easily transferring the content of the container of the package, e.g. to a syringe, a tube or a cartridge.
When withdrawing a fluid from a package as those described above, whether by piercing the stopper with a syringe or by connecting a tube or syringe to a connecting plug, the container is typically hung in an inverted position, such that the opening is pointing downwards and the fluid is allowed to run out through gravity or with the aid of an infusion pump. A challenge when withdrawing the fluid is to see the fluid level in the container, i.e. the surface of the fluid, such that the operator can make sure that only fluid is withdrawn from the container and not a bolus of air. If the operator does not see the fluid level as the container is emptying there is a risk that air will get into the syringe or tubing which is being used in the withdrawal. If air gets into the syringe or tubing, the syringe or tubing cannot be used in the procedure, and a refilling is needed, causing wasted time, wasted tubing, loss of fluid and maybe also a need to reschedule the patient examination to another day.
U.S. Pat. No. 7,338,475 of Cardinal Health discloses a drip attachment for a medical fluid administration system including a container. The drip attachment provides a chamber for collecting fluid from the container as well as a shut-off float which acts as a valve to stop fluid flow when the fluid level in the attachment is too low and to allow fluid flow when there is sufficient fluid in the attachment. Additionally, the attachment generates an electrical field that attracts a float and a valve seat to shut off flow from the exit port of the container. The disclosed attachment must be attached to the administration system by coupling a first end to the container which includes a fluid reservoir of a product fluid, such as a flexible bag or contrast media bottle, and coupling the second end to a drip line leading to a syringe which is inserted into a patient's vasculature. Additionally, the drip attachment may require connection to an electrical source so as to generate the field enabling operation of the shut-off float. The additional steps required to incorporate the drip attachment into a fluid administration system must be carefully performed to ensure proper operation of the fluid administration system.
For the reasons stated above, and for other reasons stated below, there is a need in the art for an improved package for sterile fluids providing an improved functionality wherein the content of the container of the package can easily be transferred to a delivery device such as a syringe or cartridge ensuring that fluid only is transferred and not air, without the additional expense of, or the additional steps required to connect to, a separate attachment for the container.